Early Weightbearing Versus Non-weightbearing After Operative Treatment of an Ankle Fracture

Rehabilitation Clinical Trial

Official title:

Early Weightbearing Versus Non-weightbearing After Operative Treatment of an Ankle Fracture: A Randomized Multicenter Non-inferiority Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02029170
• Other study ID #: HUKSHHOS
• Status: Recruiting
• Phase: N/A
• First received: January 6, 2014
• Last updated: October 8, 2015
• Start date: January 2014
• Est. completion date: January 2017

Study information

• Verified date: October 2015
• Source: Hallym University Medical Center
• Contact: Hyong Nyun Kim, MD, PhD
• Phone: +82-10-6377-8201
• Email: hyongnyun[@]naver.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review BoardKorea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Unstable ankle fractures are commonly treated operatively. After operative reduction and fixation of the fractures, there are varying rehabilitation regimes that include non-weightbearing for 6 weeks with active range of motion exercise in a removal cast or brace, or early protected weightbearing in a rigid cast. Several papers reported that early weightbearing may decrease ankle stiffness, muscle and bone atrophy, and aids in early return to activities. However, early weightbearing may have the risk of displacement of the fixed fractures. Rehabilitation after operative treatment of an ankle fracture is still not clear. We hypothesized that the ankle function assessed on 12 months after operation of an ankle fracture with early weightbearing is not inferior to non-weightbearing but is superior to non-weightbearing with respect to time to return to normal daily life and time to full weightbearing.

Description:

This study is a noninferiority, randomized controlled trial of patients presenting to multiple centers.

The primary outcome measure is the Olerud-Molander scores assess on 12 months after operation of an unstable ankle fracture. The Olerud-Molander scores were compared between the experimental group (early weightbearing) and the control group (non-weightbearing) on 12 month follow-up examination.

The Olerud-Molander score is a most widely used validated scale to assess ankle function after an ankle fracture. It is a self-administered patient questionnaire with a score of zero (totally impaired) to 100 (completely unimpaired) and is based on nine different items: pain, stiffness, swelling, stair climbing, running, jumping, squatting, supports and work/activities of daily living.

The secondary objectives are to determine whether early weightbearing is superior to non-weightbearing with respect to time until return to normal daily life and time to full weightbearing.

Other objectives are to determine safety by assessing number of participants with adverse effect such as hardware failure, reduction loss, non-union, or delayed union in each group.

The sample size was determined using methods appropriate for noninferiority trials, assuming 90% power and a significance level of 0.05. To find out whether the early weightbearing is not inferior to nonweightbearing after operation of an ankle fracture, 192 patients were required to have 90% power that the lower limit of an one-sided 95% confidence interval for the difference between two treatments will be above the noninferiority margin of -8, adding 20% of assumed drop-out.

Determination of the noninferiority margin was based on clinical significance. In a previous study between early weightbearing versus nonweightbearing after an ankle fracture surgery, Simanski et al. reported that both groups showed good results in the Olerud-Molander score (87 vs. 79 points; p=0.25). In both groups, the majority of patients reached their preinjury level of activity. The difference in the Olerud-Molander score between the two groups was 8 points in favor of early weightbearing. Their study came from populations similar to our trial population and from interventions similar to those being studied in the current trial. We decided that the noninferiority margin at 8 points difference will be adequate to prove noninferiority of the experiment group (early weightbearing) over the control group (nonweightbearing).

If a subject had discontinued prior to completion of 12 months, the last observation is carried forward for the intent-to-treat analysis. Subjects who crossed over to the other treatment arm, for an example, patients in non-weightbearing group who weightbear early, are analyzed according to their initial group allocation for the intent-to-treat analysis. Additionally, an as-treated (per-protocal) analysis was also conducted on patients who completed the 12 months follow-up with the protocol assigned.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: January 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• unstable ankle fracture requiring open reduction and internal fixation

• age between 18 and 65 years

• satisfactory reduction and stable fixation after operation.

Exclusion Criteria:

• open fractures

• comminuted fractures

• pathologic fractures

• Pilon fractures

• Trimalleolar fractures

• fracture dislocations

• Fractures requiring syndesmotic screw fixation

• Fractures with cartilage injuries or unstable fixation or any other conditions preventing from early weightbearing.

• Patients with diabetes or neuroarthropathy

• Patients with obesity (BMI >30, weight >100 kg)

• Any other conditions that are expected to prevent the patients from following the study protocol

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Fracture
• Ankle Fractures
• Fractures, Bone
• Rehabilitation

Intervention

Procedure:
• Early weightbearing
Patients allocated to early weightbearing group are allowed to weightbear after stitch out and application of a walking cast
• Non-weightbearing
Patients allocated to non-weightbearing group are kept non-weightbearing till 6 weeks post-operative

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Sacred Heart Hospital, Hallym University College of Medicine	Anyang-si	Gyeonggi-do
Korea, Republic of	Sanbon Hospital, Wonkwang University College of Medicine	Gunpo	Gyeongi
Korea, Republic of	CHA Bundang Medical Center, CHA University	Seongnam	Gyeongi
Korea, Republic of	Kangnam Sacred Heart Hospital, Hallym University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hallym University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (16)

Ahl T, Dalén N, Holmberg S, Selvik G. Early weight bearing of displaced ankle fractures. Acta Orthop Scand. 1987 Oct;58(5):535-8. — View Citation

Aktas S, Kocaoglu B, Gereli A, Nalbantodlu U, Güven O. Incidence of chondral lesions of talar dome in ankle fracture types. Foot Ankle Int. 2008 Mar;29(3):287-92. doi: 10.3113/FAI.2008.0287. — View Citation

Böstman OM. Body-weight related to loss of reduction of fractures of the distal tibia and ankle. J Bone Joint Surg Br. 1995 Jan;77(1):101-3. — View Citation

Burwell HN, Charnley AD. The treatment of displaced fractures at the ankle by rigid internal fixation and early joint movement. J Bone Joint Surg Br. 1965 Nov;47(4):634-60. — View Citation

Dogra AS, Rangan A. Early mobilisation versus immobilisation of surgically treated ankle fractures. Prospective randomised control trial. Injury. 1999 Aug;30(6):417-9. — View Citation

Finsen V, Saetermo R, Kibsgaard L, Farran K, Engebretsen L, Bolz KD, Benum P. Early postoperative weight-bearing and muscle activity in patients who have a fracture of the ankle. J Bone Joint Surg Am. 1989 Jan;71(1):23-7. — View Citation

Ganesh SP, Pietrobon R, Cecílio WA, Pan D, Lightdale N, Nunley JA. The impact of diabetes on patient outcomes after ankle fracture. J Bone Joint Surg Am. 2005 Aug;87(8):1712-8. — View Citation

Lehtonen H, Järvinen TL, Honkonen S, Nyman M, Vihtonen K, Järvinen M. Use of a cast compared with a functional ankle brace after operative treatment of an ankle fracture. A prospective, randomized study. J Bone Joint Surg Am. 2003 Feb;85-A(2):205-11. — View Citation

Mak KH, Chan KM, Leung PC. Ankle fracture treated with the AO principle--an experience with 116 cases. Injury. 1985 Jan;16(4):265-72. — View Citation

Olerud C, Molander H. A scoring scale for symptom evaluation after ankle fracture. Arch Orthop Trauma Surg. 1984;103(3):190-4. — View Citation

Pagliaro AJ, Michelson JD, Mizel MS. Results of operative fixation of unstable ankle fractures in geriatric patients. Foot Ankle Int. 2001 May;22(5):399-402. — View Citation

Simanski CJ, Maegele MG, Lefering R, Lehnen DM, Kawel N, Riess P, Yücel N, Tiling T, Bouillon B. Functional treatment and early weightbearing after an ankle fracture: a prospective study. J Orthop Trauma. 2006 Feb;20(2):108-14. — View Citation

Starkweather MP, Collman DR, Schuberth JM. Early protected weightbearing after open reduction internal fixation of ankle fractures. J Foot Ankle Surg. 2012 Sep-Oct;51(5):575-8. doi: 10.1053/j.jfas.2012.05.022. Epub 2012 Jul 20. — View Citation

Strauss EJ, Frank JB, Walsh M, Koval KJ, Egol KA. Does obesity influence the outcome after the operative treatment of ankle fractures? J Bone Joint Surg Br. 2007 Jun;89(6):794-8. Review. — View Citation

Tropp H, Norlin R. Ankle performance after ankle fracture: a randomized study of early mobilization. Foot Ankle Int. 1995 Feb;16(2):79-83. — View Citation

Tunturi T, Kemppainen K, Pätiälä H, Suokas M, Tamminen O, Rokkanen P. Importance of anatomical reduction for subjective recovery after ankle fracture. Acta Orthop Scand. 1983 Aug;54(4):641-7. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants with hardware failure, reduction loss, delayed union or non-union are assessed	A reduction loss or hardware failure was defined as one that occurred without patient instigation of inappropriate activity. The reduction loss or metal failure rate was to be monitored by study personnel not involved in the outcome assessment. >2 mm displacement. Delayed union was defined as a lack of bridging callus on 3 of 5 cortices at 12 weeks. Nonunion was defined as lack of cortical bridging or a clearly visible fracture line, at 14 weeks post injury.	Up to 12 month	Yes
Primary	The Olerud-Molander ankle function score	The Olerud-Molander score is a most widely used validated scale to assess ankle function after an ankle fracture. It is a self-administered patient questionnaire with a score of zero (totally impaired) to 100 (completely unimpaired) and is based on nine different items: pain, stiffness, swelling, stair climbing, running, jumping, squatting, supports and work/activities of daily living.	12 months post-operative	No
Secondary	Time to return to preinjury activity, time to full weightbearing, patients' subjective satisfactions, Visual analogue Scale (VAS)	Time to return to preinjury activity and time to full weightbearing is going to be assessed.; Patient's subjective satisfaction and VAS are going to be assessed on 12 months post-operative visit	upto 12 months	No